Treating Comorbid Pain and Depression in HIV+ Individuals

Depression Clinical Trial

— HIVPass  

Official title:

Treating Comorbid Pain and Depression in HIV+ Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766751
• Other study ID #: 840019
• Status: Completed
• Phase: N/A
• Start date: November 15, 2016
• Est. completion date: May 2021

Study information

• Verified date: June 2021
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to look at two different programs that may help people who are HIV+ and have pain and depression. The investigators are trying to understand how to help people learn to live better lives even with these chronic illnesses.

Description:

The primary aim of this RCT is to evaluate the HIVPass intervention. HIV+ participants (n=236) with chronic pain and depression will be recruited at primary care HIV Clinics through posted advertisements in the waiting rooms of the PCP offices and by physician referral. After an initial phone study screen, research staff will meet with interested individuals in their PCP offices for informed consent, baseline interview and randomization into one of two study groups (Health Education or HIVPass Counseling). Seven intervention sessions (HE or HIVPASS) will occur during the first 3 months of study participation. For all participants, the first session is a collaborative in-person joint session with the participant, his/her PCP and the study BHS. Session 2 is conducted immediately after this collaborative session, and is also in-person. Sessions 3-7 are conducted by phone. Follow-up assessment interviews will be at months 1, 2, 3 (post-intervention), 4, 6, 9 and 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: May 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic Pain (pain duration for at least six months with a mean score of greater than 3.5 on the BPI Pain Interference Scale)

• Pain severity > or equal to 4 on a Numeric Rating Scale indicating "average pain in the last week"

• At least one trial of PCP-recommended medication (i.e. acetaminophen, NSAIDS, muscle relaxants) judged through interviews with patients and PCPs

• Quick Inventory of Depression Symptoms (QIDS) score of = 9 (depression severity)

• Stable dose of an antidepressant, if using, for the previous 1 months

• Age > or equal to 18

• HIV+

• Planning to live in the area for the next 6 months

• Access to a telephone that is typically working.

Exclusion Criteria:

• In psychotherapy or a multidisciplinary pain management program

• Planned surgery in the next 6 months

• Pain thought due to cancer

• Current mania

• Past year chronic psychotic condition

• Excessive substance use (Use of cocaine, heroin, or non-prescribe opioids 15 days per month or more; binge alcohol use 4 days per month or more)

• Suicidality requiring immediate attention

• Pregnancy or planned pregnancy in the next 6 months

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV
• Pain

Intervention

Behavioral:
• HIVPASS
The 7-session HIVPASS intervention is provided to individuals randomized to the HIVPASS study arm.
• Health Education
The 7-sessions of Health Education is provided to individuals randomized to the Health Education study arm.

Locations

Country	Name	City	State
United States	Boston University/Boston Medical Center	Boston	Massachusetts
United States	Hennepin Healthcare	Minneapolis	Minnesota
United States	Butler Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain interference	Brief pain inventory, interference scale	3 months
Secondary	depression	Quick Inventory of depression symptoms	3 months; 12 months
Secondary	activity level	Assessed with actigraphy	3 months; 12 months
Secondary	anxiety	State-Trait Anxiety Inventory	3 months; 12 months
Secondary	viral load		3 months, 12 months
Secondary	ART adherence	AIDS Clinical Trial Group questionnaire	3 months, 12 months
Secondary	perception of global improvement	Patient Global Impression of Change Scale	3 months, 12 months
Secondary	health related quality of life	Short Form 36 Health Survey	3 months, 12 onths
Secondary	pain interference	brief pain inventory, interference scale	12 months